MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number	EVOLUTPRO-26-US
Medical Device Problem Codes	Calcified (1077); Gradient Increase (1270); Mechanics Altered (2984); Activation Failure (3270); Patient Device Interaction Problem (4001); Thickening of Material (4056)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Transvalvular Pressure Gradient Increased (4854)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that 8 years following the implant of a transcatheter aortic valve, high valvular gradients and calcification were identified.
Event or Problem Description
It was reported that 8 years following the implant of a transcatheter aortic valve, high valvular gradients and calcification were identified.Additional information was received that the implant depth was 3.2 mm at the non-coronary cusp (ncc) and 1.3 mm at the left coronary cusp (lcc).It was unknown if there was evidence of thrombus and leaflet thickening on the bioprosthetic valve.Restricted leaflet motion was suspected from the computed tomography (ct) imaging as the lcc appeared calcified with possible restriction in motion but it was not confirmed by the health care professional (hcp).The apparent native bicuspid aortic valve may have contributed to the high gradient.The patient was referred to the hospital to determine whether intervention would be planned to treat the failed valve.
Additional Manufacturer Narrative
Image review: a case report and two video clips were provided for review.Review of the case report showed that the valve implant appeared under-expanded, likely due to significant calcification outside the transcatheter aortic bioprosthetic valve (tav) and possible bicuspid morphology of the native valve with fusion of the right coronary cusp (rcc) and left coronary cusp (lcc).Implant depth was shallow, measuring 1.3 mm beneath both the lcc and rcc, and 3.2 mm beneath the non-coronary cusp (ncc).Protruding calcification is seen at the prosthetic commissure between the lcc and ncc inside the tav, as well as within the tav, possibly representing the prosthetic lcc leaflet tip.The 3mensio video clips include computed tomography (ct) imaging in both volume rendering and maximum intensity projection (mip) views.The mip video demonstrates restricted movement of the prosthetic lcc, which may be contributing to the elevated valvular gradients.Updated: a4, b1, b2, b5, h1, h6.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EVOLUT PRO TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24501177
• Report Number: 9617601-2026-01557
• Device Sequence Number: 9870601
• Product Code: NPT
• UDI-Device Identifier: 00643169954441
• UDI-Public: (01)00643169954441(17)191219
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2019
• Device Model Number: EVOLUTPRO-26-US
• Device Catalogue Number: EVOLUTPRO-26-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 01/15/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 55 KG